# Gynecare Innovation Center

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 8 (1996–1998): 8 510(k) clearances
- Product codes: HET (2), FJL (2), HIH (2), KNF (1), GEI (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 4 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- W.O.M. World of Medicine GmbH: 1 (https://510kreport.com/company/wom-world-of-medicine)
- ETHICON, Inc.: 1 (https://510kreport.com/company/ethicon)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Its most-cited devices
- K964441: Femrx Focused Monopolar (Fap) Operastar System [Outpatient Endoscopic Resection and Ablation (Opera)] [Specialized Tissu (1997), cited by 2
- K954775: Flo-Stat Fluid Monitoring System (1996), cited by 1
- K954648: Femrx Operastar System (1996), cited by 1

## Recent decisions
- K980393: Soprano Cryo-Therapy System (May 1, 1998)
- K971305: Femrx Focused Monopolar (FMP) Opera Star System (Aug 11, 1997)
- K964441: Femrx Focused Monopolar (Fap) Operastar System [Outpatient Endoscopic Resection and Ablation (Opera)] [Specialized Tissu (Mar 28, 1997)
- K964892: Femrx Turp SR System (TS27XX-YY/TS24XX-YY) (Feb 4, 1997)
- K963872: Femrx Morcellator System (Jan 17, 1997)
- K962506: [Specialized Tissue Aspirating Resectoscope (Star)] (Sep 16, 1996)
- K954775: Flo-Stat Fluid Monitoring System (May 10, 1996)
- K954648: Femrx Operastar System (Mar 14, 1996)

Source page: https://510kreport.com/company/gynecare-innovation-center